DEXAMETHASONE SODIUM PHOSPHATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Acute and subacute bursitis. Epicondylitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Psoriatic arthritis. Ankylosing spondylitis. 3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic diseases. Pemphigus. Severe erythema multiforme (Stevens-Johnson Syndrome). Exfoliative dermatitis. Bullous dermatitis herpetiformis. Severe seborrheic dermatitis. Severe psoriasis. Mycosis fungoides. 5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Seasonal or perennial allergic rhinitis. Drug hypersensitivity reactions. Urticarial transfusion reactions. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus. Iritis, iridocyclitis. Chorioretinitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. Anterior segment inflammation. Allergic conjunctivitis. Allergic corneal marginal ulcers. Keratitis. 7. Gastrointestinal diseases. To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy). Regional enteritis (systemic therapy). 8. Respiratory diseases: Symptomatic Sarcoidosis. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. Loeffler's syndrome not manageable by other means. Aspiration pneumonitis. 9. Hematologic disorders: Acquired (autoimmune) hemolytic anemia. Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated). Secondary thrombocytopenia in adults. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 10. Neoplastic diseases. For palliative management of: Leukemias and lymphomas in adults. Acute leukemia of childhood. 11. Edematous states. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. Nervous system. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. Trichinosis with neurologic or myocardial involvement. Diagnostic testing of adrenocortical hyperfunction. Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. Systemic fungal infections.

Product summary:

Dexamethasone Sodium Phosphate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles and is supplied as follows: NDC 51662-1541-1 100 mg per 10 mL (10 mg per mL) 10 mL Multiple-Dose Vial HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 100 mg per 10 mL (10 mg per mL) 10 mL Multiple-Dose Vials in a carton of 10 NDC 55150-305-10 Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: December 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP 100MG PER
10ML(10MG/ML*)
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
Rx only
DESCRIPTION
Dexamethasone Sodium Phosphate Injection, USP is a sterile, clear,
colorless solution,
essentially free from visible particles and a water-soluble inorganic
ester of
dexamethasone which produces a rapid response even when injected
intramuscularly.
Dexamethasone Sodium Phosphate USP, C22H28FNa2O8P, has a molecular
weight of
516.41 and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11,
17-dihydroxy-16-methyl-
21 (phosphonooxy)-, disodium salt, (11β, 16α).
It occurs as a white to practically white powder, is exceedingly
hygroscopic, is soluble in
water and its solutions have a pH between 7.0 and 8.5. It has the
following structural
formula:
Dexamethasone Sodium Phosphate Injection, USP is available in 10 mg/mL
concentration.
Each mL of Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL,
contains
10.93 mg dexamethasone sodium phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 10 mg benzyl alcohol; Made isotonic with 13.5 mg sodium
citrate, dihydrate;
and Water for Injection, q.s. pH adjusted with citric acid or sodium
hydroxide.
ACTIONS — Naturally occurring glucocorticoids (hydrocortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs are primarily used for their potent
anti-inflammatory
effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS & USAGE
A. Intravenous or intramuscular administration. When oral therapy is
not feasible and
the strength, dosage form, and route of administration of the drug
reasonably lend the
preparation to the treatment of the condition, those products labeled
for intravenous or
intramuscular